Your donation will make a difference:
Cystic Fibrosis Trust
Forum

Please Log in

Log in

Not a registered user? Register with us

This trial has been added to your watchlist.

Do you want to receive email notifications when the trial status changes?

No Yes

Unfollowing a trial will remove it from the watchlist and stop status change email notifications

Are you sure you want to unfollow this trial?

Yes, remove from watchlist

Evaluation of the High Frequency Digit Triplet test in Cystic Fibrosis

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Open to recruitment

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Not Applicable

Full title

An evaluation of the High Frequency Digit Triplet test as a screening tool for early detection of hearing loss in individuals with cystic fibrosis.

Cystic Fibrosis (CF) is an inherited condition which affects 9000 people in the UK, over half of whom are adults. Life expectancy is around 40 years but it is increasing steadily, largely due to improved treatment of chronic lung infections. However, treatment over many years with some antibiotics (“aminoglycosides”) may have toxic effects, including permanent and severe hearing loss, usually affecting both ears. Even mild hearing loss has a damaging effect on schooling and future employment prospects. The conventional hearing test - the Pure Tone Audiogram – must be performed by an audiologist using specialised equipment. It is not practical to use this test regularly in CF patients to prevent further hearing loss. We will evaluate a new hearing test - the High Frequency Digit Triplet (HFDT) test. This test mimics how individuals hear in real life situations (such as a noisy room), requires only a computer and does not need clinically trained personnel. We will evaluate the new test in stable patients and in those about to receive intravenous antibiotics for a chest infection. We will also see if it is feasible to do the test in primary school children. If the HFDT test is accurate and practical we will apply for a new research grant which would allow us to see if the test is accurate when performed in the home (where there may be more background noise). We could then offer this test to every CF patient in the UK over 5 years. Patients could perform this test at home and then bring the result to discuss with their doctor if antibiotic treatment is likely. We believe this test could prevent hearing loss in many people with CF and allow substantial savings both in testing and in hearing aid provision (where hearing is irreversibly damaged).

Trial Reference Number

27261

Trial type

Non-medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

1 day

Intervention
the name of the treatment or therapy being researched

High Frequency Digit Triplet test

Recruitment target
the number of participants who need to be recruited for the trial in the UK

388

Last edited date

25 August 2017

CF sponsor

University of Nottingham

CF sponsor type

Academic

Who can take part?

Top inclusion criteria
  • A diagnosis of CF, confirmed by genotype or sweat test, with characteristic clinical features.
  • Aged 5years and over
Top exclusion criteria
  • None. In individuals with a hearing aid, we will perform PTA and HFDT tests without the aid.
  • Individuals found to have conductive deafness after randomisation will be fully assessed for this prior to continuing with the study.

CF centres running this trial

Closed

Birmingham Children's Hospital NHS Foundation Trust

Address

Steelhouse Lane Birmingham West Midlands B4 6NH

Recruitment starts

January 2015

Recruitment ends

July 2018

Contact

Palser, Sally

Get in touch

Closed

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

February 2015

Recruitment ends

July 2018

Contact

Nash, Edward

Get in touch

Closed

Nottingham University Hospitals NHS Trust

Address

Trust Headquarters City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Recruitment starts

January 2015

Recruitment ends

July 2018

Contact

Smyth, Alan

Get in touch